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There are clear rules on the use of patient data in clinical trials in Costa Rica, as well as sanctions for any breaches, explain María del Pilar López and Esteban Monge of Zürcher Lawyers.

After years of prohibition on carrying out clinical trials in Costa Rica, this scientific practice was allowed again in the country when Biomedical Research Law No. 9234 was implemented in 2014. Regulations for this law were enacted in 2015 by means of Executive Decree No. 39061-S and were subsequently amended by Executive Decree No. 39533-S in 2016.

The current legal framework describes biomedical research as a way to develop the knowledge of health in humans, whether observational, epidemiological, interventional, experimental or clinical. All clinical trials involving human beings are governed by the principles of respect for the dignity of people, beneficence, non-maleficence, autonomy and distributive justice. In addition, participation in biomedical research must always be voluntary, so participants are not paid.

The participation of an individual in an investigation will require express consent. In addition, clinical research involving a person with a legal disability or minors may be performed only when it is expected that the results can produce real and direct health benefits. As a key fact to highlight, the National Health Research Institute (CONIS) was created as an agency of the Ministry of Health to ensure the quality of research and its strict adherence to human rights.

Within the correct course of a clinical investigation, the protection of the participants’ personal data is a key aspect which, if not treated properly, could entail potential negative effects on the investigation. Clinical investigations are founded on the collection and analysis of the most confidential information about patients, who will share sensitive information in a trusted environment while seeking an improvement of their own medical condition or just for standard investigation purposes.

According to the Law No. 8968 on the Protection of the Person Concerning the Treatment of Personal Data, information relating to health is sensitive data and no person shall be required to provide this type of information without proper consent and established legal requirements.

More specifically, Biomedical Research Law No. 9234 sets forth that there is a right to confidentiality and the use of health data for purposes other than those for which informed consent has been granted is prohibited. In addition, participants shall be entitled to confidentiality regarding their identity, personal information and health data, as well as the treatments or test results or procedures.

Exceptions

The law also sets forth some exceptions to the protection of personal data, such as when:

(i) Data is required by the scientific ethics committee that acknowledged the clinical investigation;

(ii) Data is required by CONIS in order to meet the requirements of an inspection and monitoring of an investigation;

(iii) The monitor or the auditor of research requires the information to verify the medical records for the purposes of an audit;

(iv) Data is requested by a competent judicial authority;

(v) A medical emergency occurs to the participant; and

(vi) The person responsible for clinical care needs to know that information for purposes of treating the patient.

Clear consent

An additional key aspect to take into account regarding the protection of personal data within clinical investigations is the assignment of this scientific data that could include information on relatives. In this case, the assignment of data to parties outside the investigation will also require the express written consent of the participant. If the participant’s data could also reveal personal information on relatives, the transfer to third parties shall require the express written consent of all parties concerned.

"Participants shall be entitled to confidentiality regarding their identity, personal information and health data, as well as the treatments or test results or procedures."

As is established in international medical practice, the participation of an individual in a clinical investigation requires express consent, which in the case of Costa Rica must be written, signed or fingerprinted. The information included in the informed consent must be truthful, clear, and precise, so that it is not misleading, deceptive or coercive and the participants can understand it. To this effect, it must be ensured that the procedure for signing the informed consent has the appropriate conditions for patients to correctly understand the information.

According to the law, the use of information and data concerning the health of people is prohibited for purposes not contemplated or permitted in the informed consent. The Ministry of Health, CONIS or the scientific ethical committee, whichever is appropriate, must meet and issue the appropriate health and administrative measures to prevent or amend those actions contrary to the law that researchers, sponsors or any other interested party may incur in order to intervene in a investigation project. This must be done without prejudice to any civil, criminal or disciplinary liability that may be applicable.

Clinical research is an essential part of the approval of new drugs and human health findings, and a comprehensive legal framework encourages the science and technology sector to invest in the country. However, it is of utmost importance to encourage sponsors and all parties managing the investigations to comply with all applicable rules and standards without disregarding the importance of the protection of personal data and the right to confidentiality.

This matter should be treated properly in order to avoid the invalidity of the investigation and potential penalties and sanctions. Data privacy violations within clinical investigations could lead to temporary or permanent suspension of the investigation, the investigator or approval of research projects if the administrative or judicial authority deems it necessary.

María del Pilar López is a partner at Zürcher Lawyers. She assists companies with strategic portfolio development and management, counselling on the registration of rights and promotion of innovations. López has established a life sciences and data privacy practice in order to comply with clients’ demands. She can be contacted at: plopez@zurcherip.com

Esteban Monge is an attorney at Zürcher Lawyers. He provides advice on a variety of areas of IP law, including client counselling on aspects such as product development and testing, advertisements, regulatory compliance and enforcement strategies. He can be contacted at: emonge@zurcherip.com